Purpose. This
Funding Opportunity Announcement (FOA) issued by the National Institute of
Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI)
solicits cooperative agreement grant applications from institutions to conduct basic
laboratory or ancillary research projects involving existing populations or
clinical studies focused on gene-environment interactions, as well as the
molecular mechanisms engaged, during specific windows of susceptibility that
have the potential of modifying a woman’s lifetime risk for developing
breast cancer. These activities run in parallel with a limited competition FOA to
support ongoing epidemiological investigations as well as a FOA to assume Coordinating
Functions for the Breast Cancer and Environment Research Program (BCERP; see RFA-ES-09-008 and RFA-ES-09-010, respectively). The
BCERP supports transdisciplinary research on the interactions of environmental
factors (including chemical, physical, and social environmental) with genetic
factors during windows of susceptibility throughout a woman’s lifespan that
potentially influence breast cancer risk. Each research project is required to partner
with a local community-based or advocate organization focused on breast cancer
as a concern. Community partners will assist with outreach activities to
include, but not limited to, translating and communicating research finding to
the public and policy makers as well as building and promoting partnerships
among researchers, community members, and other engaged stakeholders. The community
partners are expected to participate collaboratively with all the members of
the BCERP Network, but especially with existing Community Outreach and
Translation Cores associated with the ongoing epidemiologic investigations in
supporting communication, outreach, and translation of research findings from
the BCERP.

Mechanism of Support. This FOA will
utilize the NIH cooperative agreement (U01) grant mechanism and runs in
parallel with two additional FOAs (RFA-ES-09-008 and RFA-ES-09-010) that will collectively constitute
the Breast Cancer and Environment Research Program (BCERP) network.

Funds Available and
Anticipated Number of Awards. The total amount of funding NIEHS
and NCI expect to award through this mechanism is $2.7 million per year for
five years. It is anticipated that up to 6 awards will be made through this
announcement.

Budget and Project Period.The
total project period for an application submitted in response to this funding
opportunity may not exceed five years. Direct costs are limited to $300,000 per
year for a five-year period.

Application Research Plan Component
Length. The research plan, including specific aims, background,
preliminary studies and research design and methods sections, should be no more
than 25 pages.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with their
institution/organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support. PDs/PIs for the BCERP Windows of Susceptibility study
(this FOA) or Limited Competition Epidemiologic study (see RFA-ES-09-008) must not be the same PDs/PIs
for the Coordinating Center (see RFA-ES-09-010) but may be members of the
same institutions.

Number of PDs/PIs. More than one PD/PI
(i.e., multiple PDs/PIs), may be designated on the application.

Number of Applications.Applicants may submit
more than one application, provided they are scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to
this FOA.

Renewals.Renewal applications are not permitted in response to this
FOA.

The Purpose of this FOA (Environmental Influences during Windows
of Susceptibility in Breast Cancer Risk) is to invite applications from
eligible institutions to participate in laboratory-based and/or research
projects involving existing populations or clinical studies investigating the
influence of environmental exposures on breast cancer risk. This FOA is being
announced in parallel with two other solicitations that together will constitute
the Breast Cancer and the Environment Research Program (BCERP) Network. RFA-ES-09-008, Limited Competition:
Continuation of Studies on Early Environmental Exposures and Human Puberty
(U01), supports ongoing longitudinal studies of early environmental exposure
and human puberty previously established through the Breast Cancer and the Environment Research Centers (RFA-ES-03-001). RFA-ES-09-010, Coordinating Center for the Breast Cancer and the Environment Research Program (U01),
supports a Coordinating Center to oversee storage, management, and analytical
support for data collected in the continued epidemiological studies and facilitate
collaboration among researchers, breast cancer advocates, and community
partners involved in BCERP projects. Each BCERP grant will involve community
engagement. Collectively, the BCERP will form a network of multi-disciplinary
teams drawn from the individual research projects that will work
collaboratively to conduct high-quality, transdisciplinary research focused on
the impacts of environmental exposures on breast cancer risk. The BCERP Network
will also develop and implement strategies to translate and communicate these
research findings to appropriate stakeholders.

This FOA allows for research studies focused on the use of animal
models, in vitro cellular and molecular studies, as well as ancillary
research projects involving existing populations or clinical studies. No
new recruitment will be supported under this FOA. Rather, the
epidemiological, clinical, or population studies involving human subjects should
be adjunct, supporting investigations of associations between environmental
stressors and the risk of developing breast cancer later in life using, for
example, banked biospecimens or collection of other ancillary data. Multiple
PI projects are encouraged to promote a multidisciplinary, if not
transdisciplinary, approach. Each Window of Susceptibility project is required
to include representation from community based/advocate organizations The
community partners and the COTCs associated with the limited competition
epidemiologic studies will work together to support communication and outreach
activities related to the research findings from the BCERP. Representatives
from the community partners will also be expected to work collaboratively with
members of the COTC and members of parallel research studies on dissemination
activities (including a national Key Messages contract) that make up the BCERP
Network in supporting the development of key messages resulting from research
findings that may be disseminated locally or nationally. Community
partners may include, but are not restricted to, community and local religious
leaders, representatives of advocacy organizations or departments of health,
liaisons to Native American populations, practicing care providers, etc., with
a focus on issues related to breast cancer. Research supported through these
U01s may not exceed 5 years.

Background

Recent compelling evidence indicates that breast cancer is an
environmental disease. While exposures to environmental factors are of intense
interest to both researchers and community members, including women with breast
cancer, well conducted studies of adult women have revealed little regarding
possible environmental causes of breast cancer. The study of “windows of
susceptibility” in the etiology of breast cancer is of increasing
interest and refers to specific time periods in which breast tissue may be most
vulnerable to the effects of environmental exposures and may directly or indirectly
affect the risk of developing breast cancer. Specific windows exist when
physiologic changes occur in the mammary gland – including gestation,
puberty, pregnancy, and lactation - that likely represent time periods of
particular susceptibility to environmental factors that may influence breast
cancer risk. Thus, research focused on these critical periods of development seeks
to improve our understanding of the roles of environmental factors and their
interplay with genetic susceptibility.

The Breast Cancer and the Environment Research Centers (RFA-ES-03-001) were established in 2003, following a series of expert workshops and
town meetings with the engaged breast cancer community, including the National
Breast Cancer Coalition, the National Institute of Environmental Health
Sciences and the National Cancer Institute. The overarching goal of the
program was to address gaps in knowledge about the developmental biology of the
normal mammary gland and the physiology and genetic regulation of sexual maturation
as well as the impact of environmental stressors on these processes. The
specific aims were to:

Compare the molecular changes that occur in normal
breast development across the life span to changes that occur when
environmental exposures are introduced;

Conduct an epidemiologic study of the timing of
female pubertal events, including the onset of breast development, age at
menarche, and environmental and genetic factors that may affect pubertal
maturation; and

Integrate scientific information on the development
of the mammary gland and exposure-induced changes in order to construct public
health messages for young girls and women who are at risk for breast cancer.

The BCERP has been groundbreaking in its transdisciplinary
approaches, methodologies, and practices that utilize multiple forms of
expertise including researchers, community members and advocates in an
integrated fashion so as to generate new hypotheses and tools. The program
optimized involvement of breast cancer advocates and other community partners in
the research process to consider the etiology of environmental impact(s) on
breast cancer at the genetic, metabolic, and cellular levels, as well as
individual, physical and social levels.

The current program focused heavily on the pubertal window of
susceptibility. This FOA is intended to broaden our impact by studying
other plausible time periods. The study of multiple windows is also
acceptable.

Structure of BCERP Network

In
the second phase of the BCERP, the aims of the program remain the same.
However, the center structure will be separated into its
component elements (biology and epidemiology, each with a community
partner/COTC) and a coordinating center. All members of the
BCERP Network are expected to perform as a transdisciplinary/multidisciplinary
network. Each of the individual research projects are required to have
community input to encourage bi-directional communication between the breast
cancer advocacy community and researchers as well as to provide outreach activities
supporting translation of research findings to their constituencies and policy
makers.

To foster cross-project collaborations, members of the BCERP
Network will be required to participate in Network interactions including, but
not limited to, regularly scheduled face-to-face meetings for the exchange of
information among and across research projects, and, where appropriate,
subcommittee teleconferences or web-based communications. Aside from its
data coordinating function, the Coordinating Center will facilitate
collaborations between and among the research projects and community groups as
well as coordinate the Network interactions (face-to-face, teleconferencing,
web-based).

Governance of the BCERP Network will be through a Steering
Committee comprised of representatives from all funded grants, community
partners and COTC members, and the Coordinating Center as well as NIH program
staff. One or more subcommittees will be established to coordinate the biology,
epidemiology and community partner efforts, as appropriate. (See section,
below, on Program Governance)

Research Objectives and Requirements for Environmental
Influences During Windows of Susceptibility in Breast Cancer Risk

This FOA supports novel experimental and ancillary epidemiological,
clinical, or population studies involving human subjects focusing on the
gene–environment interactions as well as molecular mechanisms of
environmental influences on breast cancer risk operational during relevant windows
of susceptibility over the life span of an organism. Research supported by this
FOA can entail experiments using animal models appropriate for normal
development of the mammary gland, for example, by characterizing the effects of
select chemical and/or other environmental stressors (e.g., chemical, physical,
nutritional, social) on endpoints such as breast pathology and/or gene and
protein expression at critical points in time.

It is expected that research projects proposed in response to
this FOA will take advantage of the most currently available and relevant in
vitro and in vivo mammary gland biology models, recent technological
advances (imaging technologies, various “omics” approaches and
other high-throughput methods), and unique reagents. Human studies also are
encouraged; however, recruitment of new subjects to establish or expand an
existing cohort is not within the scope of this FOA. The proposed
epidemiological, clinical, population projects must be ancillary studies
associated with existing epidemiological, clinical or population studies that
are uniquely positioned to study windows of susceptibility related to breast
cancer risk.

Examples of research areas appropriate for the laboratory-based
studies covered by this FOA include, but are not limited to:

Discovery of environmentally
sensitive genes and their variants involved during windows of susceptibility
and their mechanistic role in either normal mammary gland development or breast
tumor formation.

Elucidating the mechanisms
by which environmental stressors, or other stressors such as social factors,
induce alterations that influence gene expression and morphology during
susceptible periods of breast development and function.

Exploring the impact of
elevated levels of environmental exposures reported by human studies; examination
of other potential windows of susceptibility such as pregnancy, periods from in
utero development through puberty and pre- or postmenopause.

Undertaking toxicologic studies
of the impact of endocrine disrupting chemicals, on other common chemicals, or other
hormonal responses on the mammary gland may be assessed.

Investigating the impact of
select agents, including radiation, on cellular, molecular, and epigenomic
states of mammary stem cells, or other cells, within the mammary gland microenvironment.

Exploring conditions and
exposures that induce cellular re-programming, and their roles in mammary gland
development and tumorigenesis.

It is anticipated that in the course of this work novel
biomarkers of normal and altered breast structure and/or function will be
developed. The development, validation, and integration of new and enhanced
mechanism-based screening paradigms are also encouraged. The choice and/or
methods to characterize endpoints of interest will be left to the applicant but
may include breast pathology, gene expression, and protein expression profiles
of relevant pathways and metabolomic profiles (urine and serum). The goal of
this work is to explore scientific hypothesis involved in normal mammary gland
development as well as mechanistic actions resulting in toxicologic responses
and/or carcinogenesis during these windows of susceptibility.

Examples of research areas appropriate for the
epidemiological, clinical, or population studies covered by this FOA include,
but are not limited to:

Assessing the impact of
environmental stressors during potential “windows of
susceptibility” such as pregnancy, lactation, in utero development
through puberty, and pre- and postmenopausal, on breast cancer risk.

Elucidating the mechanisms
by which genes (and/or variations thereof), either alone or in concert with
environmental exposures, modulate puberty, or other specific window of
susceptibility.

Identifying agents or
families of agents that influence gene expression during windows of
susceptibility that are related to altered breast development, involution, or
breast function.

Investigating specific
environmental exposures during a window of susceptibility within populations at
high risk of developing breast cancer, such as with a family history of breast
cancer or BRCA gene.

Investigating interactions between
environmental stressors and lifestyle factors, such as endocrine disrupting
chemicals and obesity, during specific windows of susceptibility.

For epidemiology, clinical, or population studies, each
application should include specific aims which address leading hypotheses, a
description of the existing cohort and basic design of the parent study, sample
size calculations for key hypothesis, and methods for collecting additional exposure,
health outcome, covariate data, and biological specimens. Applicants should
include a justification of how the parent study is uniquely positioned to
address hypotheses surrounding the identified window of susceptibility of
interest. Inclusion of novel biomarkers of physiological changes in
hormone status, breast development, ovarian and hormonal function, as well as
research focused on how environmental exposures may explain health disparities
in breast cancer incidence, are encouraged as secondary analyses of
pre-existing studies. Key areas of expertise for epidemiological, clinical, or
population studies include exposure assessment of chemicals and other exposures
in biological and environmental media, biostatistics, clinical assessments,
clinical laboratory determinations, and genetics, as proposed in their
applications. As previously stated, subject and patient recruitment for
epidemiologic, clinical, or population studies will not be supported by this FOA.

Successful applicants will function within the Breast Cancer
and the Environment Research Program Network. The windows of susceptibility
grantees will be expected to contribute to the collective effort by providing
new information on the normal growth and development of the breast and
reproductive systems, the mechanisms of action related to specific exposures at
the sub-cellular, cellular, and organ system levels in animal models and human
populations, the impact of environmental stressors on the mammary gland, and
the risk of developing breast cancer. Moreover, they will be expected to share
with the public and the engaged breast cancer communities, confirmed findings
on the relationship between exposures, individual susceptibility, and lifestyle
choices on breast cancer risk. Investigators are expected to share their
findings with the other BCERP Network participants at annual meetings.
Researchers are highly encouraged to engage in bi-directional collaborations,
using information derived from the epidemiology-focused efforts to inform the
direction of the basic biology. Likewise, information from the biology-based
efforts should be evaluated in the context of the epidemiology studies, when
feasible.

Community Participation:

Grantees are required to partner with breast cancer advocate(s)
and/or members of the engaged community. Applications that do not include
collaborative activities among the proposal’s leading research
scientist(s) and community partner(s) will be considered non-responsive. Community
partners may be community and local religious leaders, representatives of
advocacy organizations or health departments, liaisons to Native American
populations, practicing health care providers, etc., actively representing
breast cancer issues and concerns, and skilled in outreach, education, social
work, or public health arenas. The partnership between the research scientists
and the community partner are to draw upon the unique strengths that each
brings to the partnership. The responsibilities and goals of each of the
participants must be clearly described in the application. The partnerships
among researchers and community partners are expected to facilitate
bi-directional communication between researchers and the engaged community. The
community partner must demonstrate that they work specifically on a community-identified
concern related to environmental stressors and breast cancer risk. The
inclusion of co-investigators with additional expertise, such as a behavioral
or social scientist or health care professional engaged with the participating
community, is encouraged, if appropriate.

Responsibilities of the research scientist may include, but
are not limited to, clarifying what information the proposed study can and
cannot provide, summarizing the scientific literature on exposure-related
health risks, and interpreting study results in light of the current state of
evidence. The research scientists must document in the application the plans
and activities to include community partners at appropriate steps of planning
the specific aims of the proposal

The types of effort appropriate for community partners
includes, but are not restricted to:

Identify research questions
and ensure that the research proposal addresses the concerns of the community
with respect to environmental/occupational exposures and/or stressors that may
be related to breast cancer risk.

Translate and communicate research
findings to members of the engaged breast cancer communities to enable
individuals and families to make informed decisions in reducing potential
breast cancer risk.

Develop and disseminate
educational materials resulting from research findings to the engaged community.

Engage in outreach
activities such as workshops, forums and town hall meeting for the engaged
community.

Responsibilities of the community partner include, but are
not limited to, communicating community concerns regarding environmental exposures
of high and relevant importance, representing the community perspective when
designing the study to ensure acceptability, and helping to translate and
communicate study findings to community members, policy makers and/or other
stakeholders, as appropriate. The program should not go beyond public and
community education about reducing environmental disease risk. In
addition, the community partners are expected to participate collaboratively
with other community partners and research projects within the BCERP
Network. Their participation will also be sought in the development of
Network Key Messages resulting from the breadth of research findings emanating
from the Network as a whole, and the community partner may be asked to work
with a contractor on this aspect of the project.

Collaborations with community partners are integral to the design
and conduct of the research projects supported under this RFA. Support
for the community partners should be commensurate with the level of their
efforts on the proposed activities and fully justified in the submitted
application.

This funding opportunity
will use a cooperative agreement award mechanism. In
the cooperative agreement mechanism, the Project Director/Principal
Investigator (PD/PI) retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award".

2. Funds Available

NIEHS and NCI plan to make up to six awards
in response to this announcement. Each award is limited
to $300,000 direct costs per year. Applicants may request up to five
years.

The estimated amount of funds available
for support of theprojects awarded
as a result of this announcement is $2,700,000 for fiscal year 2010. Future year
amounts will depend on annual appropriations.

Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.

Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.

The decision of whether to
apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility
of the investigators and applicant organizations, and should be determined by
the scientific goals of the project. Applications for grants with multiple
PDs/PIs will require additional information, as outlined in the instructions
below. When considering multiple PDs/PIs, please be aware that the structure
and governance of the PD/PI leadership team as well as the knowledge, skills
and experience of the individual PDs/PIs will be factored into the assessment
of the overall scientific merit of the application. Multiple PDs/PIs on a
project share the authority and responsibility for leading and directing the
project, intellectually and logistically. Each PD/PI is responsible and
accountable to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttps://grants.nih.gov/grants/multi_pi.

PDs/PIs for the Coordinating Center (RFA-ES-09-010) must not be the same PDs/PIs
under this FOA but may be members of the same institutions.

Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and number of
this funding opportunity must be typed in item (box) 2 only of the face page of
the application form and the YES box must be checked.

Every effort should be made to comply with the
format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% Facilities and Administrative
(F&A) costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29,
2001.

Organizations must comply with Federal/NIH
policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH
biosafety and biosecurity regulations. See Section VI.2.,
“Administrative and National Policy Requirements”

Proposed research should provide special
opportunities for furthering research programs through the use of unusual
talent, resources, populations, or environmental conditions in other countries
that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL
INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are
proposed, use the Face Page-Continued page to provide items 3a – 3h for
all PD/PIs. NIH requires one PD/PI be designated as the “contact
PD/PI” for all communications between the PD/PIs and the agency. The
contact PD/PI must meet all eligibility requirements for PD/PI status in the
same way as other PD/PIs, but has no special roles or responsibilities within
the project team beyond those mentioned above. The contact PD/PI may be changed
during the project period. The contact PD/PI should be listed in block 3 of
Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the “Contact PD/PI, et. al.” The
contact PD/PI must be from the applicant organization if PD/PIs are from more
than one institution.

All individuals designated
as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI
role in that system (other roles such as SO or IAR will not give the PD/PI the
appropriate access to the application records). Each PD/PI must include their
respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled “Multiple PD/PI Leadership
Plan” must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific components
of the project or the individual PDs/PIs should be delineated in the Leadership
Plan. In the event of an award, the requested allocations may be reflected in a
footnote on the Notice of Award.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of
the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding
opportunity

Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.

Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:

Applications must be received on or before the
application receipt date described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute. Incomplete and/or non-responsive
applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously unfunded
application, originally submitted as an investigator-initiated application, is
to be submitted in response to a funding opportunity, it is to be prepared as a
NEW application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants
Policy Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new award if such costs: 1)
are necessary to conduct the project, and 2) would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Awardees must agree
to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A.

Researchers, appropriate staff, and community
partners are required to participate in the Annual BCERP Network meeting as
well as the annual integration meeting and should include funds to cover
travel.

Community partners are required to
participate in the development of key messages resulting from published
research findings.

Research Plan Page Limitations

The research plan, including specific aims, background,
preliminary studies and research design and methods sections, should be no more
than 25 pages.

Do not use
the Appendix to circumvent the page limitations. An application that does not
observe the required page limitations may be delayed in the review process.

Resource Sharing
Plan(s)

NIH considers the sharing of unique research
resources developed through NIH-sponsored research an important means to
enhance the value of, and advance research. When resources have been developed
with NIH funds and the associated research findings published or provided to
NIH, it is important that they be made readily available for research purposes
to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A genome-wide
association study is defined as any study of genetic variation across the
entire genome that is designed to identify genetic associations with observable
traits (such as blood pressure or weight) or the presence or absence of a
disease or condition. For further information see Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2. Review and Selection Process

Review
Process

Applications that are complete and responsive to
the FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by NIEHSand in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the scientific peer
review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority
score.

Receive
a written critique.

Receive
a second level of review by National Advisory Environmental
Health Sciences Council and the National Cancer Advisory Board

Relevance of the proposed project to program
priorities. The mission of the NIH is to
support science in pursuit of knowledge about the biology and behavior of
living systems and to apply that knowledge to extend healthy life and reduce
the burdens of illness and disability. As part of this mission,
applications submitted to the NIH for grants or cooperative agreements to
support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall Impact. Reviewers
will provide an overall impact/priority score to reflect their assessment of
the likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the following five core review
criteria, and additional review criteria (as applicable for the project
proposed).

Core Review Criteria. Reviewers
will consider each of the five review criteria below in the determination of
scientific and technical merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress
in the field? If the aims of the project are achieved, how will scientific
knowledge, technical capability, and/or clinical practice be improved? How will
successful completion of the aims change the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the
project? If Early Stage Investigators or New Investigators, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have complementary
and integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation.Does
the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions? Are the concepts, approaches
or methodologies, instrumentation, or interventions novel to one field of
research or novel in a broad sense? Is a refinement, improvement, or new
application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and
appropriate to accomplish the specific aims of the project are potential
problems, alternative strategies, and benchmarks for success presented? If the
project is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment.Will
the scientific environment in which the work will be done contribute to the
probability of success? Are the institutional support, equipment and other
physical resources available to the investigators adequate for the project proposed?
Will the project benefit from unique features of the scientific environment,
subject populations, or collaborative arrangements?

In addition to the above
review criteria, the following criteria will be applied to applications in the
determination of scientific merit and the impact/priority score.

Overall
assessment of the research-community partnership. Is there evidence of a partnership between research
scientist and community members, including evidence that community partners
have been involved in formulating research questions? Does the proposed
study benefit from unique features of the scientific and community members as a
collaborative research team? Is the partnership adequate to ensure
success of the proposed project?

Collaborative Strengths. Are there adequate plans for effective interaction and
coordination with the other BCERP Network components, the Steering Committee,
and the NIH? Do the investigators state their willingness to collaborate and
share information among members of the BCERP Network? Do the investigators
state their willingness to abide by the priorities and policies agreed upon by
the Steering Committee for collaborative studies?

Additional
Review Criteria

As applicable
for the project proposed, reviewers will consider the following additional
items in the determination of scientific and technical merit, but will not give
separate scores for these items.

Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections
from research risk relating to their participation according to the following
five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research
that involves human subjects and meets the criteria for one or more of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate: 1) the justification for the exemption, 2) human subjects involvement
and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities, and Children. When the
proposed project involves clinical research, the committee will evaluate the
proposed plans for inclusion of minorities and members of both genders, as well
as the inclusion of children.

Vertebrate
Animals. The committee will evaluate the involvement
of live vertebrate animals as part of the scientific assessment according to
the following five points: 1) proposed use of the animals, and species,
strains, ages, sex, and numbers to be used; 2) justifications for the use of
animals and for the appropriateness of the species and numbers proposed; 3)
adequacy of veterinary care; 4) procedures for limiting discomfort, distress,
pain and injury to that which is unavoidable in the conduct of scientifically
sound research including the use of analgesic, anesthetic, and tranquilizing
drugs and/or comfortable restraining devices; and 5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards. Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Additional
Review Considerations

As applicable
for the project proposed, reviewers will address each of the following items,
but will not give scores for these items and should not consider them in
providing an overall impact/priority score.

Budget and
Period Support. Reviewers will consider whether the budget
and the requested period of support are fully justified and reasonable in
relation to the proposed research.

Select Agents
Research. Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications
from Foreign Organizations. Reviewers will assess
whether the project presents special opportunities for furthering research
programs through the use of unusual talent, resources, populations, or environmental
conditions that exist in other countries and either are not readily available
in the United States or augment existing U.S. resources.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the Notice of Award will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.

The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award recipients
in a partnership role; it is not to assume direction, prime responsibility, or
a dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.

2.
A.1. Principal Investigator Rights and Responsibilities

The
Principal Investigator (PI) will have the primary responsibility for:

Overseeing the
budget and activities of the Windows of Susceptibility study, as detailed,
above. The Principal Investigator is expected to cooperate with the BCERP
investigators and community partners, NCI and NIEHS Program Officials and
Staff, and the Coordinating Center, when appropriate, in the design and conduct
of protocols, analysis of data, and reporting of results of research undertaken
by the BCERP.

The PI will agree to accept the participatory and
cooperative nature of the collaborative research process.

The PI will participate as a member of the Steering
Committee.

The PI will comply with Coordinating Center needs, as
directed by NIEHS and NCI Program Officials and Staff and the Steering
Committee, in monitoring BCERP progress.

The PI will assist the Coordinating Center in compiling for
the Steering Committee, necessary monthly and quarterly reports of research
activities (including, but not limited to, subject follow-up), meeting
summaries, and quarterly research site performance reports.

The PI will fully comply with federal regulatory
requirements, including but not limited to those relating to human subjects
protections, informed consent, and reporting of adverse events.

The PI will ensure training of study site personnel as
needed for standardization of collaborative protocols across sites and for
accurate and timely data entry.

Awardees will retain
custody of and have primary rights to the data and software developed under
these awards, subject to Government rights of access consistent with current
HHS, PHS, and NIH policies.

2.
A.2. NIH Responsibilities

One or more NIEHS/NCI
Program Officials will be substantially involved the BCERP Network as
NIH Project Scientists. NIH Project Scientists will have substantial scientific
and programmatic involvement that is above and beyond the normal stewardship
role in awards.

NIEHS/NCI Project
Scientist(s) will have the following responsibilities:

Have substantial involvement
to assist, guide, coordinate, and participate in the conduct BCERP Network
activities.

Attend and participate in
all Steering Committee and subcommittee meetings of the BCERP Network.

Coordinate and facilitate
the interactions among the awardees under this U01 cooperative agreement.

Serve as a liaison between
the Steering Committee, the BCERP Network, NIH and other federal agencies as
needed.

Regularly consult with the
external Breast Cancer and the Environment working group on scientific
progress.

Review the scientific
progress of individual U01 grants and their compliance with the operating
policies of the Steering Committee.

Facilitate and coordinate
the exchange of information and interactions between awardees under this U01
cooperative agreement to support collaborative efforts.

Along with the Coordinating Center, participate in organizing and coordinating annual BCERP Integration
and National Conferences.

May advise in the design of
research activities, advise on the availability of resources pertinent to the
project, and advise on the management and technical performance.

In addition to the Project Scientist(s), a designated NIEHS
Program Official will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice. The
NIEHS Program Official may recommend withholding support, suspension, or
termination of a U01 award for lack of scientific progress or failure to adhere
to policies established by the Steering Committee.

Additionally,
an agency program official or IC program director will be responsible for the
normal scientific and programmatic stewardship of the award and will be named
in the award notice.

2.A.3.
Collaborative Responsibilities

A Steering Committee will serve as the
governing board for the BCERP Network. The Steering Committee will monitor and assess
progress of epidemiologic and mechanistic studies and partnerships; determine
the need for redirection in scientific focus in order to accommodate new
knowledge and recommend new opportunities and directions for the BCERP.

The Steering Committee will be comprised of the Principal
Investigator and one COTC member from each project in “RFA-ES-09-008 - Continuation
of Studies on Early Environmental Exposures and Human Puberty,”
representatives of the supported investigators and community partners of the
related program “RFA-ES-09-009 - Environmental Influences during Windows
of Susceptibility & Breast Cancer Risk,” the PI of RFA-ES-09-010 - Coordinating
Center for the Breast Cancer and the Environment Research Program”, and NIEHS
and NCI program staff. Each represented NIH Institute will have one collective vote.
NIH staff can not serve as Steering Committee Chair. Other guidelines for the Steering
Committee, such as a quorum, will be determined at its initial meeting.

The Steering
Committee will serve as the governing board for the BCERP. The Steering
Committee will monitor and assess progress of epidemiologic and mechanistic
studies and partnerships; determine the need for redirection in scientific
focus in order to accommodate new knowledge and recommend new opportunities and
directions for the BCERP. Among its activities, the Steering Committee will
share and review annual progress among the components of the BCERP and
recommend to NIH activities in need of budget adjustments, novel opportunities
for further exploration, research and partnership aims that indicate promise or
are lagging in progress, or other priorities that will assist the BCERP program
as a whole in reaching its optimal transdisciplinary potential. In the event that individual project site principal
investigators can not reach agreement on critical aspects of the project, such
as common protocols, then the Steering Committee, in consultation with NIH
Program Staff will make final and binding decisions on how to proceed. Though the Steering Committee will make recommendations,
NIEHS and NCI Staff will have final approval and all proposed changes and
activities must comply with NIH, DHHS, and Federal Guidelines.

Each Steering Committee
member will have one vote. Awardee members of the Steering Committee will be required
to accept and implement policies approved by the Steering Committee.

2.A.4.
Dispute Resolution

Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. A Dispute
Resolution Panel composed of three members will be convened. It will have three
members: a designee of the Steering Committee chosen without NIH staff voting,
one NIH designee, and a third designee with expertise in the relevant area who
is chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility, and
health disparities related areas. The LRP is an important component of NIH's
efforts to recruit and retain the next generation of researchers by providing
the means for developing a research career unfettered by the burden of student
loan debt. Note that an NIH grant is not required for eligibility and
concurrent career award and LRP applications are encouraged. The periods of
career award and LRP award may overlap providing the LRP recipient with the
required commitment of time and effort, as LRP awardees must commit at least
50% of their time (at least 20 hours per week based on a 40 hour week) for two
years to the research. For further information, please see: http://www.lrp.nih.gov.